Thanks to Canada’s Access to Medicines Regime (CAMR) 21,000 people living with HIV in Rwanda received a generic triple fixed-dose combination antiretroviral drug called Apo-TriAvir, produced by the Canadian generic pharmaceutical manufacturer Apotex. And thanks to the completely convoluted, inefficient and backward process that is CAMR, they stopped receiving these life-saving meds after just one year—not good for their own health and not at all good in terms of avoiding future drug-resistance. A handful of the people who I respect most in the world (including the folks at the Canadian HIV/AIDS Legal Network) are fighting hard to have CAMR reformed so that it can actually work to get HIV meds where they are needed, in the quantity needed, for a price that developing countries can afford. While they valiantly slog through the process of trying to get Bills S-232 and C-393 passed by the Canadian Senate and House of Commons respectively, I would like to take this opportunity to rant about the undeniable impracticality and outright inutility of CAMR as it stands.
There are two main hurdles to getting HIV drugs (and any other drugs) to the developing countries where they are needed most. One is the cost of the drugs and the other is their patenting—both of which can be blamed on big business and their friends, like the World Trade Organization (WTO). In August 2003, in the face of 3 million deaths globally per year due to AIDS, the WTO member states (including Canada) decided to amend the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) making it legal for countries to produce and sell generic versions of patented brand-name drugs to developing countries at reduced price. While other nations turned their noses up, Canada announced that it was going to put the new law to use and CAMR came into effect in May 2005. Having looked into it recently, my opinion is that it was never intended to be used or to work—certainly not on any kind of large scale. So let’s call the government’s bluff and make it work.
A government that wishes to purchase treatments from a Canadian generic manufacturer using CAMR must first find a manufacturer willing to do so. Apotex did it once and won’t do it again until CAMR is simplified and streamlined. In order to bid on a contract to supply generic medicines to the country, a manufacturer like Apotex must first secure a compulsory license to produce and sell a generic version of a brand-name drug. To secure the license, ideally they would already have won the bid and secured the contract, which they cannot do without the license. (Yes, it’s a catch-22.) The country hoping to purchase medicine must make it known how much of which drug they would like to buy, at which point the country becomes vulnerable to bullying from the big pharmaceutical companies and even threats of economic sanctions from advanced countries if they agree to move forward with the generic. It was a struggle even to find a developing country willing to give CAMR a try.
In the case of Rwanda, the process took three years of bureaucratic wrangling and jumping through hoops. The folks at the legal network point out that the process for securing medicines using CAMR has nothing in common with the process usually used by developing countries to order drugs. The CAMR law contains many complicated clauses that require a lawyer to decipher, but it is doctors and not lawyers who normally order medicines. The main flaw, which advocates hope to rectify, is the fact that the whole cumbersome licensing process must be completed for each order of each drug for each individual country. That means that if Rwanda wishes to secure more Apo-TriAvir, it must begin the process again. If they wish to scale up their response to HIV (which ought to be a priority), they must begin the process again. Meanwhile, there are millions of people in hundreds of countries in desperate need of treatment, and they will need a variety of options to accommodate different people’s needs and combat the continual threat of drug-resistance.
Supporters of Bills S-232 and C-393 are calling for the simplification of CAMR and in particular for a “one-license solution” which would allow a generic manufacturer to secure just one license for the manufacture of a particular patented medicine that they could then legally produce and distribute in any quantity to any number of countries. If CAMR is reformed, Apotex has already committed to develop and produce a pediatric formula of Apo-TriAvir, which would save the lives of thousands of children. To learn more and to support the reform of CAMR, visit the Canadian HIV/AIDS Legal Network.
-Miriam
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This was posted on Friday, October 2nd, 2009 at 10:00 am and is filed under Education & Resources, HIV Treatment, News . Feel free to respond, or trackback. Read our comments policy.